Metastatic Castration-resistant Prostate CancerPhase 4NCT05457257
Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations
A Phase 4 study testing olaparib, enzalutamide and abiraterone acetate in people with Metastatic Castration-resistant Prostate Cancer, run by AstraZeneca at 35 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Olaparib compared with standard of care (Enzalutamide or Abiraterone Acetate) in Chinese men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have BRCA1/2 mutations. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- olaparib, enzalutamide and abiraterone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 35 sitesChina
- Study dates
- 29 Jul 2022to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of prostate cancer.
- Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
- Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .
- Ongoing therapy with LHRH analog or bilateral orchiectomy.
- Radiological progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
- Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.
- Normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
Who cannot join
- Any previous treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, including olaparib.
- Subjects who had any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose > 5 years prior to randomization.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
China35 sites
Research Site
Beijing, 100050
Research Site
Bengbu, 233004
Research Site
Changsha, 410008
Research Site
Changsha, 410013
Research Site
Chengdu, 610000
Research Site
Chongqing, 408099
Research Site
Fuzhou, 350005
Research Site
Guangzhou, 510060
Research Site
Guangzhou, 510180
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310009
Research Site
Hangzhou, 310014
Research Site
Hefei, 230601
Research Site
Jiaxing, 314001
Research Site
Jinan, 250012
Research Site
Jinan, 250021
Research Site
Jining, 272029
Research Site
Kunming, 650101
Research Site
Lanzhou, 730030
Research Site
Linyi, 276000
Research Site
Nanchang, 330006
Research Site
Nantong, 226361
Research Site
Ningbo, 315010
Research Site
Shanghai, 200002
Research Site
Shanghai, 200032
Research Site
Shenyang, 110004
Research Site
Suzhou, 215004
Research Site
Taiyuan, 030000
Research Site
Tianjin, 300060
Research Site
Wanzhou, 404000
Research Site
Wuhan, 430022
Research Site
Wuxi, 214002
Research Site
Wuxi, 214023
Research Site
Xi'an, 710077
Research Site
Zhengzhou, 450052
About this study
Official title: A Randomized, Open-label Study to Assess the Efficacy and Safety of Olaparib Versus Enzalutamide or Abiraterone Acetate in Chinese Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations (PROfound-CN)
The purpose of this study is to evaluate the efficacy and safety of Olaparib compared with standard of care (Enzalutamide or Abiraterone Acetate) in Chinese men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have BRCA1/2 mutations.
Read the detailed description
This is a Phase IV, randomized, open-label, 2-arm, multicenter study evaluating the efficacy and safety of olaparib in Chinese men with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have BRCA1/2 mutations. Approximately 42 subjects will be randomized in a 2:1 ratio to olaparib or to investigator's choice of NHA (enzalutamide or abiraterone acetate).
- Being tested
- olaparib, enzalutamide, abiraterone acetate, Prednisone
- Keywords
- metastatic castration-resistant prostate cancer (mCRPC), BRCA1/2 mutations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olaparibDrug
Also called Lynparza
300 mg (2x 150 mg tablets) twice daily
enzalutamideDrug
Also called XTANDI
160 mg (4 x 40 mg capsules) once daily
abiraterone acetateDrug
Also called ZYTIGA
1,000 mg (4 x 250 mg tablets) once daily
PrednisoneDrug
5mg(5mg x 1 tablet) twice daily
| Study group | Role | What they receive |
|---|---|---|
| Olaparib | Experimental | Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose of 300 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions Receives: Drug: olaparib |
| Enzalutamide OR abiraterone acetate | Active comparator | Enzalutamide:
Enzalutamide is available as capsules or tablets containing 40 mg of enzalutamide. Subjects will be administered study treatment orally at a dose of 160 mg once daily.
Abiraterone acetate with prednisone: Abiraterone acetate is available as tablets containing 250 mg of abiraterone acetate. Subjects will be administered study treatment orally at a dose of 1,000 mg once daily. Prednisone is 5mg twice daily. Prednisolone is permitted for use instead of prednisone if necessary. Receives: Drug: enzalutamide; Drug: abiraterone acetate; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Progression-free Survival - Based on Blinded Independent Central Review (BICR)
rPFS is defined as the time from randomization until the date of objective disease progression (soft tissue or bone) or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.
Measured: Tumor assessments every 8 weeks (± 1 week) relative to the date of randomization until radiological progression as assessed by BICR or death (median duration of treatment of 9 and 6 months for Olaparib and Investigators Choice of NHA respectively).
Secondary outcomes (8)
Confirmed Objective Response Rate (ORR), Based on Blinded Independent Review (BICR)
Confirmed ORR is the percentage of patients with a Complete response (CR) or Partial response (PR), in their soft tissue disease per (RECIST v1.1), in the absence of progression on bone scan per Prostate Cancer Working Group 3 (PCWG3), confirmed >=4 weeks later. Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions. For each treatment group, confirmed ORR is the number of patients with a confirmed CR or PR divided by the number of patients in the treatment group.
Measured: Tumor assessments every 8 weeks (± 1 week) from randomisation until radiographic progression assessed by BICR (median duration of treatment of 9 and 6 months for Olaparib and Investigators Choice of NHA respectively).
Overall Survival
OS is the time from the date of randomization until death due to any cause.
Measured: From the time from the date of randomization until death due to any cause. Assessments continue up to 27 months after the first patient was randomized.
Time to First Symptomatic Skeletal-related Event
Time from first dose to the first symptomatic skeletal-related event
Measured: Time from randomization to the first SSRE-radiation for skeletal symptoms, confirmed pathological fracture, confirmed spinal cord compression, or orthopaedic surgery for bone metastases. Assessments continue up to 27 months post first patient enrolled.
Time to Opiate Use for Cancer-related Pain
Time from randomization to opiate use for cancer-related pain
Measured: Opioid use will be recorded at baseline and at every study visit, including the safety follow-up visit. Assessments continue up to 27 months post first patient enrolled.
Prostate-specific Antigen Response
Proportion of participants achieving a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later (PSA50 response)
Measured: Blood samples for PSA assessment will be collected at baseline and every 4 weeks throughout the treatment phase, including at the study treatment discontinuation visit. Assessments continue up to 27 months post first patient enrolled.
Prostate-specific Antigen Response
Best percentage change from baseline in PSA is defined as the biggest reduction in PSA level compared with baseline (or the smallest increase in the absence of a reduction) taking account of all PSA values collected for each patient.
Measured: Blood samples for PSA assessment will be collected at baseline and every 4 weeks throughout the treatment phase, including at the study treatment discontinuation visit. Assessments continue up to 27 months post first patient enrolled.
Time From Randomization to Second Progression or Death
Time from randomization to second progression by investigator assessment of radiological or clinical progression or death (PFS2)
Measured: Tumor assessments will be performed every 8 weeks (±7 days) after randomization until radiologic progression or death, unless the participant withdraws consent. Assessments continue up to 27 months post first patient enrolled.
Subsequent Anticancer Therapy
Measured: Recorded from post discontinuation of study treatment up to primary data cut off date. Assessments continue up to 27 months post first patient enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start29 Jul 2022
- Primary completion22 Oct 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC, Foundation Medicine, Myriad Genetics, Inc.
- Responsible party
- Sponsor
- Investigators
- Fangjian Zhou, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457257
- Sponsor's protocol ID
- D081LC00002
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2022
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment（https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure). "Yes" indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study to Assess the Efficacy and Safety of Olaparib Versus Enzalutamide or Abiraterone Acetate in Chinese Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations (PROfound-CN)
- ClinicalTrials.gov ID
- NCT05457257
- Acronym / sponsor ID
- D081LC00002
- Keywords
- metastatic castration-resistant prostate cancer (mCRPC), BRCA1/2 mutations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC, Foundation Medicine, Myriad Genetics, Inc.
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Olaparib compared with standard of care (Enzalutamide or Abiraterone Acetate) in Chinese men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have BRCA1/2 mutations.
Detailed description
This is a Phase IV, randomized, open-label, 2-arm, multicenter study evaluating the efficacy and safety of olaparib in Chinese men with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have BRCA1/2 mutations. Approximately 42 subjects will be randomized in a 2:1 ratio to olaparib or to investigator's choice of NHA (enzalutamide or abiraterone acetate).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olaparib | Experimental | Drug: olaparibOlaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose of 300 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions |
| Enzalutamide OR abiraterone acetate | Active comparator | Drug: enzalutamide, Drug: abiraterone acetate, Drug: PrednisoneEnzalutamide: Enzalutamide is available as capsules or tablets containing 40 mg of enzalutamide. Subjects will be administered study treatment orally at a dose of 160 mg once daily. Abiraterone acetate with prednisone: Abiraterone acetate is available as tablets containing 250 mg of abiraterone acetate. Subjects will be administered study treatment orally at a dose of 1,000 mg once daily. Prednisone is 5mg twice daily. Prednisolone is permitted for use instead of prednisone if necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of prostate cancer.
- Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
- Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .
- Ongoing therapy with LHRH analog or bilateral orchiectomy.
- Radiological progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
Key exclusion criteria (4 listed)
- Any previous treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, including olaparib.
- Subjects who had any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose > 5 years prior to randomization.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olaparibAlso: Lynparza300 mg (2x 150 mg tablets) twice daily | Drug | Olaparib |
| enzalutamideAlso: XTANDI160 mg (4 x 40 mg capsules) once daily | Drug | Enzalutamide OR abiraterone acetate |
| abiraterone acetateAlso: ZYTIGA1,000 mg (4 x 250 mg tablets) once daily | Drug | Enzalutamide OR abiraterone acetate |
| Prednisone5mg(5mg x 1 tablet) twice daily | Drug | Enzalutamide OR abiraterone acetate |
Primary outcome
Radiological Progression-free Survival - Based on Blinded Independent Central Review (BICR)
Time frame: Tumor assessments every 8 weeks (± 1 week) relative to the date of randomization until radiological progression as assessed by BICR or death (median duration of treatment of 9 and 6 months for Olaparib and Investigators Choice of NHA respectively).
rPFS is defined as the time from randomization until the date of objective disease progression (soft tissue or bone) or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.
8 secondary outcomes
Confirmed Objective Response Rate (ORR), Based on Blinded Independent Review (BICR)
Time frame: Tumor assessments every 8 weeks (± 1 week) from randomisation until radiographic progression assessed by BICR (median duration of treatment of 9 and 6 months for Olaparib and Investigators Choice of NHA respectively).
Overall Survival
Time frame: From the time from the date of randomization until death due to any cause. Assessments continue up to 27 months after the first patient was randomized.
Time to First Symptomatic Skeletal-related Event
Time frame: Time from randomization to the first SSRE-radiation for skeletal symptoms, confirmed pathological fracture, confirmed spinal cord compression, or orthopaedic surgery for bone metastases. Assessments continue up to 27 months post first patient enrolled.
Time to Opiate Use for Cancer-related Pain
Time frame: Opioid use will be recorded at baseline and at every study visit, including the safety follow-up visit. Assessments continue up to 27 months post first patient enrolled.
Prostate-specific Antigen Response
Time frame: Blood samples for PSA assessment will be collected at baseline and every 4 weeks throughout the treatment phase, including at the study treatment discontinuation visit. Assessments continue up to 27 months post first patient enrolled.
Prostate-specific Antigen Response
Time frame: Blood samples for PSA assessment will be collected at baseline and every 4 weeks throughout the treatment phase, including at the study treatment discontinuation visit. Assessments continue up to 27 months post first patient enrolled.
Time From Randomization to Second Progression or Death
Time frame: Tumor assessments will be performed every 8 weeks (±7 days) after randomization until radiologic progression or death, unless the participant withdraws consent. Assessments continue up to 27 months post first patient enrolled.
Subsequent Anticancer Therapy
Time frame: Recorded from post discontinuation of study treatment up to primary data cut off date. Assessments continue up to 27 months post first patient enrolled.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment（https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure). "Yes" indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fangjian Zhou, M.D. principal investigator
Sun Yat-Sen University Cancer Center
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing olaparib, enzalutamide and abiraterone acetate in people with Metastatic Castration-resistant Prostate Cancer, run by AstraZeneca at 35 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological Progression-free Survival - Based on Blinded Independent Central Review (BICR) (time frame: Tumor assessments every 8 weeks (± 1 week) relative to the date of randomization until radiological progression as assessed by BICR or death (median duration of treatment of 9 and 6 months for Olaparib and Investigators Choice of NHA respectively).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.